ZIRTEC * 7CPR RIV 10MG

ZIRTEC * 7CPR RIV 10MG

Therapeutic indications

Cetirizine dihydrochloride 10 mg film-coated tablets are indicated in adults and pediatric patients from 6 years of age: - for the treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis. - for the symptomatic treatment of chronic idiopathic urticaria.

Dosage and method of use

Dosage:10 mg once daily (1 tablet).Special populations. Elderly people:Based on available data, no dose reduction is required in elderly subjects with normal renal function.Renal impairment:There are no data available documenting the efficacy / safety ratio in patients with renal impairment. Since cetirizine is predominantly excreted via the kidney (see section 5.2), in cases where alternative treatments cannot be used, the dose intervals should be individualized according to renal function. Refer to the following table and adjust the dose as indicated. To use this dosing table, an estimate of creatinine clearance (CL_cr) of the patient expressed in ml / min. The CL_cr(ml / min) can be obtained starting from the serum creatinine value (mg / dl) using the following formula:

Dosage adjustment for adults with impaired renal function.

: Patients with hepatic impairment only do not require any dose adjustments. Dose adjustment is recommended in patients with hepatic and renal impairment (see aboveRenal impairment).Pediatric population:The tablet formulation should not be used in children under 6 years of age as it does not allow for the necessary dose adjustments. Children between 6 and 12 years of age: 5 mg twice a day (half a tablet twice a day). Adolescents over 12 years of age: 10 mg once daily (1 tablet). In pediatric patients with renal impairment, the dose should be individually adjusted taking into account the renal clearance, age and body weight of the patient.Method of administration:The tablets should be taken with a glass of liquid.

Contraindications

Hypersensitivity to the active substance, to any of the excipients listed in section 6.1, to hydroxyzine or to any derivative of piperazine. Patients with severe renal impairment with creatinine clearance less than 10 ml / min.

Side effects

Clinical Studies.•In general:Clinical studies have shown that cetirizine at the recommended dosage has minor CNS undesirable effects, including somnolence, fatigue, dizziness and headache. In some cases, paradoxical CNS stimulation has been reported. Although cetirizine is a selective antagonist of H₁peripheral and relatively free of anticholinergic activity, isolated cases of difficulty in micturition, visual accommodation disturbances and dry mouth have been reported. There have been reports of abnormal liver function with elevated liver enzyme levels accompanied by elevated bilirubin, most of which resolved following discontinuation of cetirizine dihydrochloride. •List of adverse reactions.In double-blind controlled clinical trials comparing cetirizine versus placebo or other antihistamines at the recommended dosage (10 mg daily for cetirizine), for which quantitative safety data are available, they were exposed to cetirizine. more than 3200 subjects. Based on these data, the following adverse reactions were reported in placebo-controlled trials with an incidence of 1.0% or greater with cetirizine 10 mg:

Although statistically the incidence of somnolence is more common than with placebo, this event was mild to moderate in the majority of cases. Further studies in which objective tests have been carried out have shown that usual daily activities are not compromised at the recommended daily dose in young healthy volunteers.Pediatric population:Adverse reactions with an incidence of 1.0% or greater in children aged 6 months to 12 years in placebo-controlled clinical trials are:

In addition to the adverse reactions from clinical trials listed in the previous section, the following undesirable effects have been reported during post-marketing experience. Undesirable effects are described according to MedDRA by system organ class and according to the frequency defined based on post-marketing experience. Frequencies are defined as follows: very common (≥1 / 10); common (≥1 / 100, Blood and lymphatic system disorders. Very rare: thrombocytopenia.Disorders of the immune system.Rare: hypersensitivity; Very rare: anaphylactic shock.Metabolism and nutrition disorders.Not known: increased appetite.Psychiatric disorders.Uncommon: agitation; Rare: aggression, confusion, depression, hallucinations, insomnia; Very rare: tics; Not known: suicidal ideation, nightmare.Nervous system disorders.Uncommon: paraesthesia; Rare: convulsions; Very rare: dysgeusia, syncope, tremor, dystonia, dyskinesia; Not known: amnesia, memory impairment.Eye disorders.Very rare: accommodation disorder, blurred vision, oculogyration.Ear and labyrinth disorders.Not known: vertigo.Cardiac pathologies.Rare: tachycardia.Gastrointestinal disorders.Uncommon: diarrhea.Hepatobiliary disorders.Rare: impaired liver function (elevation of transaminases, alkaline phosphatase, γ-GT and bilirubin); Not known: hepatitis.Skin and subcutaneous tissue disorders.Uncommon: pruritus, rash; Rare: urticaria; Very rare: angioneurotic edema, fixed drug eruption; Not known: acute generalized exanthematous pustulosis.Musculoskeletal and connective tissue disorders.Not known: arthralgia.Renal and urinary disorders.Very rare: dysuria, enuresis; Not known: urinary retention.General disorders and administration site conditions.Uncommon: asthenia, malaise; Rare: edema.Diagnostic tests.Rare: weight gain.Description of selected adverse reactions:Pruritus (intense itching) and / or urticaria have been reported after discontinuation of cetirizine treatment.Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

At therapeutic doses, there was no evidence of clinically significant interactions with alcohol (for blood alcohol levels of 0.5 g / l). However, caution is advised in case of concomitant alcohol intake. Caution should be exercised in patients with predisposing factors for urinary retention (e.g. spinal cord injury, prostatic hyperplasia) as cetirizine may increase the risk of urinary retention. Caution is advised in epileptic patients and in patients at risk for seizures. The response to allergy skin tests is inhibited by antihistamines and a wash-out period (of 3 days) is required before performing them. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take cetirizine film-coated tablets. Itching and / or hives may occur when treatment with cetirizine is stopped, even if these symptoms were not present before the start of treatment. In some cases, symptoms can be intense and treatment may need to be restarted. Symptoms should resolve when treatment is restarted.Pediatric population:The use of the film-coated tablet formulation is not recommended in children under 6 years of age as this formulation does not allow for appropriate dose adjustment. It is recommended that a pediatric formulation of cetirizine be used.

Pregnancy and breastfeeding

Pregnancy:Prospective data collected for cetirizine on pregnancy outcomes do not suggest potential maternal or fetal / embryo toxicity above baseline. Animal studies do not show direct or indirect harmful effects with respect to pregnancy, embryonal / fetal development, parturition or postnatal development. Prescribing to pregnant women should be done with caution.Feeding time:Cetirizine passes into breast milk. A risk of undesirable effects in breast-fed infants cannot be excluded. Cetirizine is excreted in breast milk at concentrations representing 25% to 90% of those measured in plasma, depending on the sampling time after administration. Therefore, prescribing to breastfeeding women should be done with caution.Fertility:Limited data on human fertility are available but no safety concerns have been identified Animal data show no safety concerns for human reproduction.

Expiry and retention

This medicine does not require any special storage conditions.

Interactions with other drugs

Due to the pharmacokinetic, pharmacodynamic and tolerability profile of cetirizine, no interactions are expected with this antihistamine. In drug-drug interaction studies, in fact, neither pharmacodynamic nor significant pharmacokinetic interactions were reported, in particular with pseudoephedrine or theophylline (400 mg / day). The extent of absorption of cetirizine is not reduced by food, although the rate of absorption is decreased. In sensitive patients, concomitant intake of cetirizine with alcohol or other CNS depressant substances may cause a further decrease in alertness and impaired performance, although cetirizine does not potentiate the effect of alcohol (0.5 g / L blood levels).

Overdose

SymptomsSymptoms observed following an overdose of cetirizine are mainly associated with central nervous system effects or with effects that may suggest anticholinergic activity. Following a dose of at least 5 times the recommended daily dose, the following adverse events have been reported: confusion, diarrhea, dizziness, fatigue, headache, malaise, mydriasis, pruritus, restlessness, sedation, somnolence, stupor, tachycardia, tremor and urinary retention.TreatmentA specific antidote to cetirizine is not known. In the event of an overdose, symptomatic or supportive treatment is recommended. Gastric lavage may be considered if a short time has passed since ingestion of the medicine. Cetirizine is not effectively removed by hemodialysis.

Active principles

Each film-coated tablet contains 10 mg of cetirizine dihydrochloride. Excipients with known effect: one film-coated tablet contains 66.40 mg of lactose monohydrate. For the full list of excipients, see section 6.1.

Excipients

- Microcrystalline cellulose, - Lactose monohydrate, - Colloidal anhydrous silica, - Magnesium stearate; - Opadry Y-1-7000 which consists of:- Hydroxypropylmethylcellulose (E 464), - Titanium dioxide (E 171), - Macrogol 400.